1. Frequency and Severity of Hypoglycemia Under Conditions of Increased Hypoglycemic Risk with Insulin Efsitora Alfa Versus Insulin Glargine Treatment in Participants with Type 2 Diabetes.
- Author
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Heise, Tim, Andersen, Grit, Pratt, Edward J., Leohr, Jennifer, Fukuda, Tsuyoshi, Wang, Qianqian, Kazda, Christof, Bue-Valleskey, Juliana M., and Bergenstal, Richard M.
- Subjects
TYPE 2 diabetes ,HYPOGLYCEMIA ,INSULIN therapy ,INSULIN - Abstract
Introduction: Insulin efsitora alfa (efsitora) is a basal insulin with a flat pharmacokinetic profile and long half-life, enabling weekly dosing. These attributes may provide stable glucose levels. This exploratory phase 1 study aimed to assess the hypoglycemic risk during experimental conditions that mimic situations encountered in daily life. Methods: This was a single-site, open-label, two-period, fixed-sequence study in participants with type 2 diabetes (T2D) previously treated with basal insulin. The incidence, duration, and nadir glucose of hypoglycemia were assessed after treatment with efsitora versus insulin glargine (glargine) during three provocation conditions: 24-h prolonged fasting, prolonged fasting with exercise, and double dosing of study insulin. Results: The 54 enrolled adults (BMI 21.8–39.7 kg/m
2 , HbA1c 6.5–9.4%) achieved stable fasting glucose before undergoing provocation. Most hypoglycemic events were level 1 (≥ 54 to < 70 mg/dL) and resolved spontaneously or after oral glucose. The incidences of level 1 hypoglycemia for efsitora and glargine were not significantly different: for prolonged fasting, the incidences were 44.7 vs. 42.6% and the difference in proportion was 2.1% (95% CI: – 17.2, 21.4); for prolonged fasting with exercise, the corresponding values were 65.9 vs. 50.0% and 15.9% (– 3.0, 34.8); for double dosing, the corresponding values were 68.1 vs. 61.7% and 6.4% (– 12.8, 25.6). Level 2 hypoglycemia (< 54 mg/dL) was infrequent during both treatments and all provocations. No severe hypoglycemia was observed. Mean nadir glucose (range 62.8–66.3 mg/dL) and hypoglycemia duration (range 76.6–115.2 min) were also similar for the two treatments, depending on the provocation. Conclusion: Overall, weekly efsitora did not increase the incidence, duration, or severity of hypoglycemia compared to daily glargine during provocation periods in patients with T2D. Trial Registration: ClinicalTrials.gov identifier NCT04957914. [ABSTRACT FROM AUTHOR]- Published
- 2024
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